Label: NOBLEAID CAPSAID- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 7, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Capsaicin 0.1%.

  • PURPOSE

    Purpose

    Topical Analgesic Cream.

  • INDICATIONS & USAGE

    Uses temporarily relieves minor aches and pains of muscles adn joints due to

    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to capsicum or chili peppers

    When using this product

    • avoid contact with the eyes and mucus membranes
    • a transient burning sensation may occur upon application but generally disappears in a few days
    • do not bandage tightly
    • do not apply heat to treated area

    Stop use and ask a doctor if

    • condition worsens or if symptoms last more than 7 day or clear up and occur again within a few days.
    • redness or irritation develop.
    • a severe burning sensation occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • read all warnings adn directions before use. Test first on a small area of skin.
    • adults and children 18 years of age and older: apply adn massage on to affected area not more than 3 to 4 times daily
    • children under 18 years of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredienta:

    Benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-40 hydrogenated castor oil, petrolatum, sorbitol, water

  • SPL UNCLASSIFIED SECTION

    Manufactured for

    Noble OTC LLC

    788 Convery Blvd

    Perth Amboy, NJ 08861

    www.nobleotc.com

    609-375-2548

    MADE IN MEXICO

  • PRINCIPAL DISPLAY PANEL

    NobleAid

    CapsAid ES

    ARTHRITIS PAIN RELIEF

    TOPICAL ANALGESIC CREAM

    CAPSAICIN 0.1%

    ODOR FREE

    NDC: 81533-100-15

    NET WT. 1.5 OZ (42.5G)

    CapsAid Final

  • INGREDIENTS AND APPEARANCE
    NOBLEAID CAPSAID 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-100-151 in 1 CARTON08/31/2021
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81533-100-99108000 g in 1 DRUM; Type 0: Not a Combination Product10/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2021
    Labeler - Noble OTC LLC (041836435)
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